ISO
14644-7, Cleanrooms and associate controlled environments - Part 7:
Separative devices (clean air hoods, gloveboxes, isolators and
minienvironments), may be ordered directly
through IEST. ISO 14644-7 was published as an International Standard in
2004. The document was submitted as an American National Standard and
has been adopted as ANSI/IEST/ISO 14644-7:2004.

Introduction
IEST
has responsibility to ISO/TC 209 for convening Working Group 7 and
producing an acceptable standard. The standard was developed from a
"blank sheet" of paper because a precedence-setting document did not
exist. The scope and content has evolved significantly over the last six
years.Formation
ISO/TC 209
established WG 7 in late 1994. The first meeting of the working group
was held in April 1995. The scope ultimately given to WG 7 in 1995 was
as follows:

The scope of the WG 7 shall be to define performance
requirements in areas of minienvironments and isolators. These
requirements will focus on ways that minienvironments differ from
cleanrooms in the area of monitoring, design, testing, molecular
contamination, material compatibility, integrity, and microbial
contamination.

It was clear from the onset that this standard
would be very ambitious from a number of aspects. First, as mentioned,
no precedent-setting document existed to match the broad scope of the
working group, although some documents existed covering limited parts of
the scope.

WG 7 had to define the aspects of how these devices
differed from cleanrooms. Therefore, a number of policy decisions needed
to be made during the development of the document. First, a common set
of process requirements were identified, setting this equipment apart
from just "a little cleanroom." It is clear that these devices, usually
located with cleanrooms, exist to create conditions that cannot be found
in a cleanroom. Examples include very clean conditions, special
atmospheres, and physical barriers to protect workers from hazardous
materials. Typically, personnel work outside these devices and
manipulate tools, processes, and products inside with access devices.
Access devices include manual approaches such as glove systems and
automatic robotics handling systems. Transfer devices are used to move
material in and out of the device.

Based on the common set of
process needs, it was decided to write a single standard. Even though a
common technology core exists, the balancing of various industrial needs
in the document has proven to take a great deal of work.

The
working group name was changed from "Minienvironments and isolators" to
"Separative devices" by ISO/TC 209. Separative devices, while not a
perfect description, could be translated without altering the meaning
and would not be confused with terms used in cleanrooms or other fields.
The changing of a name may seem like a very insignificant event;
however, it had the effect of allowing the working group drafting the
document to focus on the generic aspects of the core technical
requirements. The requirements in the standard were written to be
completely generic and would apply to all industrial applications.
Therefore, the need to write industry-specific annexes became
unimportant. The current scope for the draft is as follows:

This
part of ISO 14644 specifies the minimum requirements for the design,
construction, installation, testing, and approval of separative devices
in those respects where they differ from cleanrooms as described in ISO
14644-4 and 14644-5. Separative devices range from open to closed
systems.

The limitations are:

Application-specific requirements are not addressed.

User requirements are as agreed by customer and supplier.

Specific processes to be accommodated in the separative device installation are not specified.

Fire,
safety, and other regulatory matters are not considered specifically;
the appropriate national and local requirements shall be respected.